The healthcare industry in the U.S. drives an annual health related spending of approximately $2 trillion. Goods and services are provided by manufacturers of drugs, medical devices, and other supplies, with combined revenue of $300 billion, and by care providers—doctors, hospitals, clinics, nursing homes, etc., with combined annual revenue of $1.5 trillion. Most of the costs for healthcare is funded by private health insurers and government health insurance programs such as Medicare and Medicaid, with the private sector funding approximately $700 billion annually and the government providing combined annual payments of $1 trillion. Of the $1.5 trillion care provider market, the Managed Healthcare segment makes up approximately $350 billion.
This segment of the industry provides various types of health insurance plans designed with means of controlling the cost of healthcare related spending. The major products include health maintenance organizations (HMO's), preferred provider organizations (PPO's), point of services plans, and indemnity benefit plans.
The industry has expanded over the last decade on the premise that the traditional way of delivering healthcare was financially wasteful. Managed care companies attempt to control costs in four ways: by providing financial incentives to providers and users to minimize the amount of care used, contracting for services at discounted rates, reviewing expenses to determine the legitimacy of costs, and establishing low-cost treatment protocols providers are expected to follow. They are in effect, administrative intermediaries between healthcare providers and users.
In addition to using financial incentives to limit unnecessary medical care, managed healthcare companies use “utilization management” to review and standardize care. Committees of doctors and administrators review the actual services used in the network to determine if they're being used appropriately, and to recommend standards of care that doctors and hospitals are expected to follow. Committees also determine drug formularies that specify which drugs should be used to treat specific conditions. The statistical information collected for utilization management is also used for risk management and underwriting, the process of determining what payments to offer providers and what premiums to charge consumers. Computerized information and communications systems are vital to managed healthcare companies to process claims and manage records, and for statistical collection and analysis.
What appears to be an underdeveloped set of opportunities is preventive care and healing process management. According to PricewaterhouseCoopers, preventative care and disease management programs have untapped potential to enhance health status and reduce costs, a win for managed care and for the consumer.
Delivering care involves complex inter-relationships among multidisciplinary providers of various services and products. Opportunities for waste are rife. HealthCast 2020 survey respondents said sustainability depends on incentivizing clinicians, hospitals, pharmaceutical companies and payers to integrate care and manage chronic conditions together. The present applicant believes there is another critical component in this complex set of relationships, the patient. Wellness, prevention, and treatment regime compliance ultimately begins and ends with the patient. Patients are notoriously ineffective in maintaining compliance with their treatment regimes. Effectively integrating delivery, diagnostics, and communication into a single patient friendly system is expected to dramatically improve patient treatment outcomes and at the same time reduce cost and improve profitability for healthcare providers.
The pharmaceutical dosage form that may best be utilized to achieve the above described integration of functionality and technology is a patch or transdermal system. The currently available patch and transdermal technologies do not possess these capabilities and there is thus a need for an improved product that addresses and overcomes these deficiencies.
A transdermal drug delivery system is a system that delivers a dose of medication through the skin, for either local or systemic distribution. Often this promotes healing to a specific injured area of the body. An advantage of a transdermal drug delivery system over other types of drug delivery systems, such as oral, topical, etc., is that is provides a controlled release of the medicament into the patient. A wide variety of pharmaceuticals can be delivered via a transdermal drug delivery system.
One commonly found transdermal drug delivery system is a transdermal patch. A typical transdermal patch includes the following components: (1) a liner that protects the patch during storage and is removed prior to use; (2) a drug solution in direct contact with the release liner; (3) an adhesive that serves to adhere the components of the patch together along with adhering the patch to the skin; (4) a membrane that controls the release of the drug from the reservoir and multi-layer patches; and (5) a backing that protects the patch from the outer environment.
There are at least four different types of transdermal patches. One type is a single-layer drug-in adhesive where the adhesive layer of this system also contains the drug. The adhesive layer is surrounded by a temporary liner and a backing. A second type is a multi layer drug-in adhesive in which both adhesive layers are also responsible for the releasing of the drug; however, in this system, another layer of drug-in-adhesive is added. This path also has a temporary liner-layer and a permanent backing. A third type of path is a reservoir type that has a separate drug layer that is a liquid or semi-solid compartment containing a drug solution or suspension separated by the adhesive layer. A fourth type of patch is a matrix system that has a drug layer of a semisolid matrix containing a drug solution or suspension. An adhesive layer surrounds the drug layer partially overlaying it.
The limitations of these passive systems is that they are typically only effective in delivering (i) low molecular weight (<500 Da) compounds, (ii) lipophilic compounds, and (iii) potent compounds requiring low dosage (20-25 mg).